A Study to Assess the Tolerability and Safety of Subcutaneously (SC) Administered Immunoglobulin G (IgG) With Varying Injection Conditions

NCT07025577 | Completed Phase 1

• 1 other identifier: GP45580
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 3

Brief Summary

This study will evaluate the safety and tolerability of SC administration of IgG in healthy participants.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (8)

• Mean Injection Site Tolerability Score on a Visual Analogue Scale (VAS)

  Up to Day 4

• Mean Change From Baseline in Injection Site Tolerability Score on VAS

  Baseline, Up to Day 4

• Percentage of Participants Experiencing Greater Than Mild Pain

  Up to Day 4

• Percentage of Participants in Each VDS Category on the VDS Scale

  Up to Day 4

• Percentage of Participants with Local Injection Site Reaction Using Local Injection-site Symptom Assessment (LISSA)

  Up to Day 7

• Participant's Tolerability to Injection as Assessed by Tolerability Questionnaire

  Up to Day 4

• Number of Participants with Visual Injection Site Tolerability as assessed using LISSA

  Up to Day 4

• Number of Participants with Fluid Leakage

  Up to Day 4

Study Arms (4)

Sequence 1

EXPERIMENTAL

Participants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment A.

Drug: Immunoglobulin G

Sequence 2

EXPERIMENTAL

Participants will receive SC administrations of IgG into the abdominal region starting with Treatment A, followed by Treatment C.

Drug: Immunoglobulin G

Sequence 3

EXPERIMENTAL

Participants will receive SC administrations of IgG into the abdominal region starting with Treatment D, followed by Treatment C.

Drug: Immunoglobulin G

Sequence 4

EXPERIMENTAL

Participants will receive SC administrations of IgG into the abdominal region starting with Treatment B, followed by Treatment D.

Drug: Immunoglobulin G

Interventions

Immunoglobulin G DRUG

Participants will receive SC administrations of IgG

Sequence 1; Sequence 2; Sequence 3; Sequence 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) 18 to 36 kilograms per meter square (kg/m\^2), inclusive
• For females of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during IgG administration and for 28 days after completion of IgG administration
• For males: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

You may not qualify if:

• Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the last study drug administration
• Positive human immunodeficiency virus (HIV) test
• Positive hepatitis B surface antigen or hepatitis B core antibody test
• Positive hepatitis C virus antibody test
• Regular alcohol consumption of \>8 drinks/week for females or \>12 drinks/week for males
• Poor peripheral venous access
• Major surgical procedure within 28 days prior to initiation of study treatment or anticipation of need for a major surgical procedure during the study
• Known hypersensitivity to IgG or any of its components or to products made with IgG
• History or presence of skin rash or other skin disorders
• Inability to sense pain (e.g., peripheral neuropathy) or have a history of or have been diagnosed with a chronic pain syndrome
• Infection or inflammation of the designated injection site (abdomen)

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (3)

Daytona Beach Clinical Rsch Unit

Daytona Beach, Florida, 32117, United States

Location

Fortrea Clinical Research Unit - Dallas

Dallas, Texas, 75247-4989, United States

Location

Fortrea Clinical Research Unit Inc. - Madison

Madison, Wisconsin, 53704-2526, United States

Location

MeSH Terms

Interventions

Immunoglobulin G

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 17, 2025
• Study Start: June 2, 2025
• Primary Completion: August 8, 2025
• Study Completion: September 3, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)